A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Korábbi kezelés

• History of acute or chronic pancreatitis (within 1 year prior to first administration) or long-term alcohol abuse
• Previous participants with malignant tumors other than CML.
• Serious infections occurred within 4 weeks prior to the first administration.
• Major surgery (craniotomy/thoracotomy/laparotomy) within 12 weeks prior to first dose.
• Other toxicities from prior antineoplastic therapy with severity of Grade ≥2.

Más betegség

• Known to have major congenital or acquired hemorrhagic diseases unrelated to the disease under study
• Impaired cardiac function or cardiac repolarization abnormality.
• Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
• Severe or uncontrolled diabetes mellitus.
• Severe or uncontrolled hypertension.
• Serious arteriovenous thrombosis events.
• History of splenectomy, solid organ or bone marrow/hematopoietic stem cell transplantation, excluding corneal transplantation.
• Presence of known active infectious disease.
• Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
• History of severe neurological or mental disorders.
• Have a history of severe allergies or allergic reactions to any components of HS-10382 and TKIs selected by the investigators.
• Any other condition deemed by the investigator to interfere with the participant's ability to participate in the study, not covered above.

Egyéb

• It is known that there is an accelerated or rapidly changing phase of CML
• It is known that atypical CML (non P210 protein) exists
• Known presence of central nervous system leukemia or primary chronic myelofibrosis (excluding secondary myelofibrosis grade 1 caused by CML)
• Clinically significant gastrointestinal dysfunction.
• Pregnant or lactating female participants, or those planning pregnancy during the study.

• Men or women who are ≥ 18 years old at the time of signing the informed consent form
• The physical condition score (PS) of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 1
• First diagnosis of Ph+CML-CP within the first 3 months of randomization: positive for Ph chromosome t (9; 22) in bone marrow cytogenetics and/or positive for BCR/ABL fusion gene in molecular biology testing
• Organ function testing meets protocol requirements and is deemed eligible.
• Female participants of childbearing age are willing to take appropriate contraceptive measures and should not breastfeed from the time of signing informed consent until 6 months after the last use of the study treatment; Male participants were willing to use barrier contraception (i.e. condoms) from the time of signing informed consent until 6 months after the last use of the study treatment. The TKI participants selected by the researchers can follow the contraceptive requirements in the TKI instructions.
• Female participants who have a negative blood pregnancy test result or documented evidence of no pregnancy risk.
• Voluntarily participate in this clinical trial, understand the research procedures, and be able to sign a written informed consent form